Catalog Number

-

Brand Name

electrodeEchoCUR

Version/Model Number

CUR-101022U

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 13, 2020

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GXI

Product Code Name

Probe, Radiofrequency Lesion

Public Device Record Key

d2145f5f-291a-4835-b069-69b2b3840bc5

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

October 24, 2016

Package DI Number

08132500165810

Quantity per Package

10

Contains DI Package

08132500165292

Package Discontinue Date

August 13, 2020

Package Status

Not in Commercial Distribution

Package Type

-